8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRATUS CS D-DIMER
FDA 510(k)
FDA Class 2
·Hematology
SMARTMONITOR 2, MODEL 4000
FDA 510(k)
FDA Class 2
·Anesthesiology
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INQWIRE DIAGNOSTIC GUIDE WIRE
FDA Adverse Event
Injury
·MERIT MEDICAL SYSTEM, INC.·Product code DQX·January 17, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 10, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 12, 2011
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS CORP·Product code MCM·May 19, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012